Lecicarbon Iunior

Leaflet attached to the packaging: information for the user

Lecicarbon Junior, 250 mg + 340 mg, suppositories

Sodium hydrogen carbonate + Sodium dihydrogen phosphate
For use in children

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist.
Keep this leaflet, you may need to read it again.
If you need advice or additional information, consult a pharmacist.
If the patient experiences any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist.
See section 4.
If after 3 days there is no improvement or the patient feels worse, consult a doctor.

Table of contents of the leaflet

• 1. What is Lecicarbon Junior and what is it used for
• 2. Important information before using Lecicarbon Junior
• 3. How to use Lecicarbon Junior
• 4. Possible side effects
• 5. How to store Lecicarbon Junior
• 6. Other information

1. What is Lecicarbon Junior and what is it used for

Lecicarbon Junior is used for various forms of constipation, e.g. caused by consuming foods that do not contain sufficient fiber, lack of physical activity, or diseases that require easy bowel movements.
Lecicarbon Junior is also used to empty the intestines before surgery or diagnostic procedures in the rectal area.

2. Important information before using Lecicarbon Junior

When not to use Lecicarbon Junior

if the patient is allergic (hypersensitive) to sodium hydrogen carbonate, sodium dihydrogen phosphate, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

In cases of toxic megacolon (pathological dilation of the end of the large intestine for various reasons), the medicine should only be used after obtaining the explicit consent of the attending physician.

Lecicarbon Junior and other medicines

Lecicarbon Junior can be used while taking other medicines.
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription.

Lecicarbon Junior with food and drink

No special precautions are necessary.

Pregnancy, breastfeeding, and fertility

Pregnancy:
Lecicarbon Junior can be used during pregnancy after consulting a doctor.
Breastfeeding:
Lecicarbon Junior can be used during breastfeeding.
Fertility:
There are no data on the effect of Lecicarbon Junior on human fertility. The effect on male and female fertility has not been evaluated in animal studies.
Before using any medicine, consult a doctor or pharmacist.

Driving and using machines

Lecicarbon Junior has no effect on the ability to drive vehicles and operate machines.
However, note that the effect (bowel movement) is expected 15-30 minutes after application.

Lecicarbon Junior contains (3-sn-phosphatidyl)choline (from soybean oil, lecithin)

Do not use in case of known hypersensitivity to peanuts or soy.

3. How to use Lecicarbon Junior

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
Unless otherwise instructed, insert one suppository into the rectum when needed. If necessary, the dose can be repeated after 30-60 minutes.

Before using Lecicarbon Junior, remove it from the packaging by separating one suppository from the blister pack at the perforation. Hold the plastic ends with both hands and pull in opposite directions. Insert the suppository into the rectum. Brief pre-soaking in water facilitates the insertion of the suppository. In the case of children, it may be necessary to squeeze both buttocks of the child to avoid immediate expulsion of the suppository. The effect starts after 15-30 minutes.
Do not use oil or petroleum jelly as a lubricant.
Lecicarbon Junior is suitable for use in children under 12 years of age. Lecicarbon Junior is not suitable for use in adults.
Lecicarbon Junior is safe for long-term use and does not lead to habituation. However, in cases of chronic constipation, always consult a doctor.

Using a higher dose of Lecicarbon Junior than recommended

The usual dose is one suppository. If necessary, the dose can be repeated after 30-60 minutes. In case of overdose, there is no danger, but it makes no sense to administer more than two suppositories.

Missing a dose of Lecicarbon Junior

Lecicarbon Junior is used only when needed.

Stopping the use of Lecicarbon Junior

Lecicarbon Junior is used only when needed.
In case of any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Lecicarbon Junior usually does not cause any problems (side effects).
Insertion of the suppository may sometimes, in rare cases, cause a mild burning sensation, which quickly subsides.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Lecicarbon Junior

Store and transport in a cool place (2°C – 8°C).
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after: "Expiry date (EXP)". The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Lecicarbon Junior contains

The active substances are sodium hydrogen carbonate and sodium dihydrogen phosphate.
The other ingredients are: (3-sn-phosphatidyl)choline (= soy lecithin, phosphatides), solid fat, and anhydrous colloidal silica.

What Lecicarbon Junior looks like and contents of the pack

Lecicarbon Junior is a cream-colored suppository, homogeneous, torpedo-shaped, packaged in PVC/PE blisters of 5 pieces, with the batch number and expiry date printed.
It is available in packs of 10 suppositories and in hospital packs containing 5x10 suppositories.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

athenstaedt GmbH & Co KG
Am Beerberg 1
D-35088 Battenberg (Eder)
Germany
Tel. +49 6452 92 942-0
Fax. +49 6452 92 942-15

Manufacturer:

Haupt Pharma Livron S.A.S.
1 Rue Comte de Sinard
F-26250 Livron-Sur-Drôme
France
Tel.: +33-4-75 61 02 00,
Fax: +33-4-75 61 02 10

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany:

Lecicarbon E/K CO2-Laxans two/three

Hungary:

Lecicarbon Felnött végbélkúp/Lecicarbon Gyermek végbélkúp

Luxembourg:

Lecicarbon E/K

Slovenia:

Lecicarbon za odrasle 500 mg/680 mg svečke / Lecicarbon® za otroke 250 mg/340 mg svečke

Slovakia:

Lecicarbon Pediatrickí pacienti 0,250 g/0,340 g čapíky

Date of last revision of the leaflet: